FDAClass IIJune 16, 2021

Quanta System Sterile Optical Laser Fiber recall: Sterility Concern

Quanta System Sterile Optical Laser Fiber, reusable

Why was Quanta System Sterile Optical Laser Fiber recalled?

Product sterility is potentially compromised.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Part Numbers: OAF002013 Lots A201003 OAF005513 Lots A184636, A192118, A193101 OAF006003 Lot A195008 OAF008003 Lots A193615, A194021 OAF008013 Lots A183623, A192119 OAF009903 Lots A193109, A193617 OAF009913 Lots A181350, A192910 OAF702713 Lots A182415, A193104, A194109, A194723 OAF703613 Lot A180150

Product
Quanta System Sterile Optical Laser Fiber, reusable
Recalling firm
Quanta System, S.p.A.
Quantity
307
Distribution
Nationwide distribution via 6 US distributors
Recall date
June 16, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls